GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT— 510(k) K772029

Substantially Equivalent

Harleco

FDA 510(k) clearance K772029 for GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT, Substantially Equivalent on 1977-11-15. Applicant: Harleco.

Clearance details

Applicant: Harleco
Product code: Code CIT
Advisory panel: Clinical Chemistry
Date received: 1977-10-27
Decision date: 1977-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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